Kornimate/medical-research-clean huggingface dataset:
comparison of non-invasive blood pressure (nibp) using the biobeat device with an invasive arterial line catheter

Conditions: Blood Pressure; Heart Diseases

Summary: in this clinical study the investigators will compare blood pressure measurements obtained using the non-invasive, wireless biobeat monitoring device (both a wrist watch and a patch configuration) to an invasive arterial line catheter (radial or femoral) and a swan ganz catheter in 20 patients immediately after cardiac surgery, at the cardiac intensive care unit.

the biobeat non-invasive, wireless monitoring device is based on reflective photoplethysmograph (ppg) technology. it measures several vital signs, including blood pressure, stroke volume, pulse rate, pulse pressure, heart rate variability, respiratory rate, saturation, cardiac output, cardiac index, and more. the data is transmitted to biobeat's application (in both apple and google play), and is available on the individual's cellular phone, tablet, or as a full monitoring system in a hospital department. the aim of this study is to compare the biobeat monitor with the invasive method of blood pressure measurement, an arterial line, and a swan ganz catheter for measurements of cardiac output and stroke volume. the study population includes 20 patients undergoing cardiac surgery. as per local protocol, each one of the participants will come out from the operating room with an arterial line, some will also have a swan ganz catheter. once in the intensive care unit, the investigators will attach the biobeat non-invasive monitor (both a wristwatch and a patch), these two configurations are identical in terms of the monitoring system), and monitor the participants for 4 hours. though both methods are continuous, the investigators will record the vital signs every 15 minutes during the 4 hours of the study.

Eligibility criteria:
inclusion criteria: * 18 years old and above patients of both sexes arriving immediately after cardiac surgery to the intensive care unit with a radial/femoral arterial line and or a swan ganz catheter and in need for blood pressure monitoring. exclusion criteria: * refusal to participate * patients with no need or no technical capability to have an arterial line * pregnant women * individuals under the age of 18 years * patients with lack of judgment/mental illness * patients working in the sheba medical center

Keywords: vital signs blood pressure cardiac surgery non-invasive monitoring
influence of binge drinking on glucose metabolism in patients with type 1 diabetes - a pilot study

Conditions: Diabetes Mellitus, Type 1

Summary: although there is no evidence that individuals with type 1 diabetes have a different approach to alcohol compared to the background population, nevertheless, its use does have implications for patients mainly because of the risk of hypoglycaemia unawareness. however, binge drinking has been implicated as a factor in the development of ketoacidosis and is probably under-recognised. the aim of this study is to examine the effect of binge drinking on glucose, insulin, counter-regulatory hormones and other metabolites in patients with type 1 diabetes. it is hoped that data from this project will be used to develop a larger study comparing different treatment regimens for patients using alcohol to reduce the risks of hyperglycaemia as well as hypoglycaemia.

this is a randomised trial involving type i diabetics who have had type i diabetes \>5 years. they will be using multiple daily injections of a basal insulin and a rapid acting component.apart from insulin and oral contraceptive, none will be on regular medication. all will be regular consumers of modest amount of alcohol (female - less than or equal to 14 units, males - less than or equal to 21 units). each will participate in 2 studies. subjects will be randomised either to white wine or an equivalent volume of alcohol-free wine.outcome measures are the results of the effect of acute ingestion of alcohol on glucose levels and intermediate metabolites in subjects with type i diabetes.

Eligibility criteria:
inclusion criteria: * type 1 diabetes for \> 5 years * use of multiple daily injections of a basal insulin and a rapid acting component * regular consumption of modest amounts of alcohol exclusion criteria: * type 2 diabetes * type i diabetes \< 5 years * excessive alcohol consumption * unstable diabetes
a study to assess the pharmacokinetics and safety of recombinant human murine chimeric anti cd20 monoclonal antibody injection (ibi301) compared to rituximab injection in cd20 positive b cell lymphoma patients

Conditions: B-Cell Lymphoma

Summary: randomised, double-blind, parallel group study to compare pk and pd profiles between ibi301 and rituximab in patients with cd20+ b-cell lymphoma


Eligibility criteria:
inclusion criteria: 1. cd20-positive b-cell lymphoma. 2. 18 years to 65 years. 3. eastern cooperative oncology group (ecog) performance status of 0 to 1. 4. signed an informed consent. 5. obtained cr (complete remission) or cru (uncertain complete remission) after the prior therapy. exclusion criteria: 1. participation in another interventional clinical trial in the past 28 days. 2. known allergic reactions against monoclonal antibody or rituximab. 3. rituximab and other anti-cd20 monoclonal antibody used in the past 4 months. 4. blood concentration of rituximab\>24ug/ml. 5. hiv positive patients. 6. hcv antigen and antibody positive. 7. acute and chronic hepatitis b virus infection.
induction chemotherapy followed by chrono-chemotherapy concurrent with imrt of locally advanced npc clinical study

Conditions: Nasopharyngeal Carcinoma

Summary: comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.


Eligibility criteria:
inclusion criteria: 1. pathological diagnosis of early cure ⅲ - ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 uicc staging criteria, t3-4, n0-3), no evidence of distant metastasis (m0). a measurable tumor lesions; 2. karnofsky score≥70; 3. age 18-70 years old, male or female; 4. no major organ dysfunction; normal bone marrow hematopoietic function (white blood cell ≥4．0×109／l，platelet≥100×109 /l. hemoglobin ≥100g/l)，normal liver function (total bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of normal) electrocardiogram does not affect the normal treatment; 5. to understand this study and sign informed consent form. exclusion criteria: 1. a distant metastasis; 2. patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study; 3. pregnancy (confirmed by serum or urine β-hcg test) or between lactation period; 4. serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.who had received radiation and chemotherapy.
extended ecg monitoring in hcm patients

Conditions: Hypertrophic Cardiomyopathy; Nonsustained Ventricular Tachycardia; Ventricular Tachycardia; Atrial Fibrillation; Arrhythmia

Summary: the purpose of this study is to determine, among a large cohort of 300 consecutive patients with hypertrophic cardiomyopathy, if extended ambulatory monitoring using the irhythm technologies, inc. zio xt device results in identifying a greater burden of nonsustained ventricular tachyarrhythmia (nsvt) compared to current accf/aha guideline recommended 48-hour monitoring.

optimal duration to monitor patients for identifying nsvt remains unclear. the investigators aim to determine the prevalence and burden of nsvt with longer term monitoring with the irhythm zio xt device over a 2-week period vs. 48 hours; and whether, this greater burden of nsvt compared to conventional shorter monitoring potentially identifies a subset of hcm patients who may be at higher risk of sudden cardiac death.

Eligibility criteria:
inclusion criteria: * subject must be 18 to 65 years of age at time of informed consent and must not be a member of a vulnerable population. * subject has been diagnosed with hypertrophic cardiomyopathy, as defined by a maximal lv wall thickness of ≥15 mm anywhere in lv wall, in absence of another cause that could be responsible for the lv hypertrophy. * subject eligible to receive the zio xt device per the current approved indications for use. exclusion criteria: * subject with pacemaker * known skin allergies or reaction to adhesives * the investigator deems a condition that could limit a subject's ability or unwillingness to participate in the study, comply with study required monitoring and/or follow-up visits.

Keywords: electrocardiography electrocardiogram mobile cardiac monitoring ambulatory monitoring ecg ekg
periodontal health and its relationship with psychological stress

Conditions: Periodontal Diseases; Stress; Mucositis; Periodontal

Summary: studies suggest that chronic exposure to psychological stress can lead to oral health deterioration, alter the immune response, and possibly contribute to increased inflammation, which can impact the physiological healing of periodontal tissues. people with psychophysiological stress disorders tend to acquire unhealthy habits, leading to less self-care, incorrect nutrition, smoking, alcohol consumption, and reduced physical activity. this cross-sectional study aims to evaluate the correlation between periodontal health and psychological stress. patients between the ages of 35 and 70 will be recruited. each patient must be visited and a periodontal assessment must be performed, recording the percentage of bleeding on probing and the periodontal screening and recording (psr). subsequently, patients will be administered the sheldon cohen perceived stress scale (pss) and the mindfulness awareness attention scale (maas) questionnaires.


Eligibility criteria:
inclusion criteria: * aged \> 18 exclusion criteria: * pregnancy * administration of antibiotics in the last 15 days prior to study entry or indications for antibiotic prophylaxis; * orthodontic appliances * immunological diseases or use of drugs that can affect oral tissues, (phenytoin, cyclosporine), nifedepine, chronic use of non-steroidal anti-inflammatory drugs);

Keywords: periodontal disease
continous quadratus lumborum block for hepatic surgery with right subcostal incision

Conditions: Hepatectomy; Analgesia; Nerve Block

Summary: this prospective, randomized study, control study aims to compare the analgesic effect, opioids consumption, quality of recovery, length of hospital stay and et al. between unilateral continuous quadratus lumborum block (qlb) and intravenous patient-controlled analgesia (ipca) alone in patients undergoing hepatectomy with right j-shape subcostal incision.


Eligibility criteria:
inclusion criteria: * age 18-70 yrs * american society of anesthesiologists physical statusⅰ-ⅲ * undergo hepatectomy with right j-shape subcostal incision * informed consent exclusion criteria: * a known allergy to the drugs being used * coagulopathy, on anticoagulants * analgesics intake, history of substance abuse * participating in the investigation of another experimental agent * inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
hyperbaric oxygen for post concussive syndrome

Conditions: Post-Concussion Syndrome

Summary: we would like to see if hyperbaric oxygen can help improve the symptoms that result from post concussive syndrome.

purpose: the purpose of this study is to examine the role of hyperbaric oxygen therapy (hbot) in decreasing symptoms in patients with a diagnosis of chronic post concussive syndrome (pcs). hypothesis: the study hypothesis is that hbot will decrease symptoms measured by standard measurement tools when provided to patients who have a diagnosis of pcs and are 6 months to 36 months post injury. study overview: hyperbaric oxygen therapy (hbot) involves the administration of inhaled 100% oxygen at increased ambient pressure inside a closed vessel. hbot produces greatly elevated arterial and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular and sub cellular level. participants will be selected from the post-concussive syndrome population based on an expectation that they would experience a clinically significant improvement. eligible subjects will be experiencing post concussive symptoms related to an injury within the last 6 to 36 months. the study will be enrolling 150 participants and will be randomized to two different treatment arms: experimental group and a waitlist group. each participant will receive a series of forty 2 hour treatments, delivered once a day, 5 days a week, within the hyperbaric oxygen chamber.there will be assessments completed before treatment series begins, at the end of treatment, 8 months and 14 months after treatment begins. the primary outcome will be administered at these times as well as every two weeks once treatment begins until the end of the study.

Eligibility criteria:
inclusion criteria: * able to speak english and give informed consent. * a diagnosis of chronic pcs made by a referring physician * time of injury between 6 and 36 months previously * able to sit in the chamber for 120 minutes. exclusion criteria: * untreated collapsed lung (pneumothorax) * have taken the chemotherapy drug doxorubicin within 72 hours * have taken the chemotherapy drug bleomycin within 4 months * bowel obstruction * heart pacemaker that has not been certified as safe for exposure to 2.0 ata * pregnancy * severe chronic obstructive pulmonary disease (copd) * participation in other pcs related studies. * previous recent hbot * previous recent deep sea diving experience

Keywords: hyperbaric oxygen pressurized oxygen concussion post concussive syndrome oxygen therapy
eufuro - eus-based follow-up on r0-resected patients for esophageal, gastric and pancreatic cancer

Conditions: Esophageal Cancer; Stomach Cancer; Pancreatic Cancer

Summary: follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic. this is because the methods and the consequence of following these patients is unknown. therefore the investigators will randomize these patients in to two groups: 1. one group of patients will be offered visits with a specialist surgeon in a outpatient setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is the current standard at our department. 2. the other group will be offered endoscopic ultrasound, eus, and pet/ct with the same intervals as the first group.


Eligibility criteria:
inclusion criteria: * r0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.
the effect of eating frequency on blood pressure

Conditions: Blood Pressure

Summary: the primary purpose of this study is to identify the effect of meal frequency on blood pressure (bp) levels of individuals.

migration studies, observational epidemiology and clinical trial data indicate that causes of adverse bp levels are mainly environmental , including lifestyle under which dietary factors play a role. therefore, lifestyle modification is part of the current american heart association recommendations for prevention and control of adverse bp levels. although the effects of nutrients and foods on bp have been studied extensively, other dietetic factors such as eating frequency and number of meals in a day have been less thoroughly investigated and warrant further research to explore their possible positive effect on bp.

Eligibility criteria:
inclusion criteria: healthy individuals aged 35-70 years with prehypertension (systolic/diastolic bp 120-139/80-89 mm hg) bmi 20-30 kg/m2 non-smoking non alcoholic drinkers exclusion criteria: * weight change of ≥ 3kg in the preceding 2 months * current smokers * substance abuse * alcohol intake * pregnancy * diabetes * cardiovascular disease * cancer * gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome * kidney disease * liver disease * pancreatitis * use of medications including: anti inflammatory drugs or steroids, antihypertensive drugs, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.

Keywords: blood pressure eating episode eating frequency insulin sensitivity
diabetes control and complications trial (dcct)

Conditions: Type 1 Diabetes Mellitus

Summary: background. long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (iddm). we examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications. methods. a total of 1441 patients with iddm -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. the patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.


Eligibility criteria:
eligibility criteria: * the major criteria for eligibility included insulin dependence, as evidenced by deficient c-peptide secretion; an age of 13 to 39 years; and the absence of hypertension, hypercholesterolemia, and severe diabetic complications or medical conditions. to be eligible for the primary-prevention cohort, patients were required to have had insulin dependent diabetes mellitus (iddm) for one to five years, to have no retinopathy as detected by seven-field stereoscopic fundus photography, and to have urinary albumin excretion of less than 40 mg per 24 hours. to be eligible for the secondary-intervention cohort, the patients were required to have iddm for 1 to 15 years, to have very-mild to moderate nonproliferative retinopathy, and to have urinary albumin excretion of less than 200 mg per 24 hours.
setup study for hugotm ras inguinal hernia repair

Conditions: Inguinal Hernia

Summary: the goal of this observational cohort study is to evaluate the evolution of the operative time in performing robotic assisted laparoscopic inguinal hernia repair (rtapp) during the learning curve of the first 50 patients using the hugotm ras (medtronic) robotic system using the setup guide. researchers will compare to the operative time for rtapp of 50 patients by the same surgeon in another hospital using the davinci xi (intuitive surgical) robotic system.

as a result of human cadaveric sessions to evaluate the approach of inguinal hernia repair using the hugo ras robotic system a setup guide was produced. preclinic tests on dummies, cadaveric models and porcine models were performed. during a first session using dummies, the existing set-up guide proposed by us surgeons was tested and validated. to evaluate the evolution of the operative time in performing robotic assisted laparoscopic inguinal hernia repair (rtapp) during the learning curve of the first 50 patients using the hugotm ras (medtronic) robotic system using the setup guide at the sint vincentius hospital in deinze. this will be compared to the operative time for rtapp of 50 patients by the same surgeon in general hospital maria middelares using the davinci xi (intuitive surgical) robotic system. patient data and outcome data will be collected. a follow-up of 1 month postoperative is foreseen for the evaluation of short-term complications and quality of life 1 month after surgery.

Eligibility criteria:
inclusion criteria: all patients planned for a minimal invasive (robotic assisted laparoscopic) inguinal hernia repair during the study period will be invited to take part in the study. both unilateral and bilateral hernias will be included. exclusion criteria: * recurrent hernias after previous preperitoneal mesh placement. * inguinal hernias after abdominal prostatectomy. * pregnancy. * emergency surgery. * age below 18 years. * absence of informed consent.

Keywords: robot-assisted laparoscopic inguinal hernia repair
intervention study of an individualized exergame training for people with major neurocognitive disorder

Conditions: Exergame; Major Neurocognitive Disorder; Long-term Care Facility; Nursing Home

Summary: this study evaluates the feasibility of the intervention and the study design.

this study evaluates the feasibility of the intervention and the study design. furthermore, it investigates the effects of an exergame training including strength, balance, cognitive and pelvic floor muscle training. the main risk in this study is related to potential accidents/falls during the training (and not mainly to the data acquisition procedures). but as the difficulty of the training game is adaptive, the participants will always be challenged on an appropriate level for their physical condition. furthermore, before and after the training period, several low risk measurements are conducted. this study contributes to fundamental research investigating how multicomponent exergame training influence physical and cognitive functions.

Eligibility criteria:
inclusion criteria: * aged 60+ years * living in residency "de wingerd" in leuven (at least two weeks here) * being able to straight for minimal 10 minutes without aids * visual acuity with correction sufficient to see on a tv screen * diagnosed with major neurocognitive disorder exclusion criteria: * mobility impairments that don't allow to play the exergame * any unstable cardiovascular or other health condition which according to the american college of sports medicine standards might lead to unsafe participation (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension) * orthopaedic or neurological diseases that prevent exergame training * rapidly progressive or terminal illness
a retrospective study of cardiovascular events related to the use of glucose lowering drug treatment in primary care

Conditions: Diabetes Type II

Summary: to describe the type ii diabetes population in primary care with special reference to treatment, other diseases and mortality during the last decade. to test the hypothesis that the type or combination of per oral glucose lowering drugs have different effects on the risk of cardiovascular disease and diabetic complications.


Eligibility criteria:
inclusion criteria: * patients with type ii diabetes, according to medical records, diagnosis, prescription or lab assessments exclusion criteria: * patients followed by physician for less than 6 months after diagnosis of diabetes type ii

Keywords: epidemiological diabetes glucose lowering drug treatment in primary care cvd